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  • ISSN 1006-3080
  • CN 31-1691/TQ

CHO细胞培养生产抗体产量的稳定性

张进 王星懿 范里 谭文松

张进, 王星懿, 范里, 谭文松. CHO细胞培养生产抗体产量的稳定性[J]. 华东理工大学学报(自然科学版), 2017, (6): 806-814. doi: 10.14135/j.cnki.1006-3080.2017.06.009
引用本文: 张进, 王星懿, 范里, 谭文松. CHO细胞培养生产抗体产量的稳定性[J]. 华东理工大学学报(自然科学版), 2017, (6): 806-814. doi: 10.14135/j.cnki.1006-3080.2017.06.009
ZHANG Jin, WANG Xing-yi, FAN Li, TAN Wen-song. Titer Stability of Antibody Produced by CHO Cell Culture[J]. Journal of East China University of Science and Technology, 2017, (6): 806-814. doi: 10.14135/j.cnki.1006-3080.2017.06.009
Citation: ZHANG Jin, WANG Xing-yi, FAN Li, TAN Wen-song. Titer Stability of Antibody Produced by CHO Cell Culture[J]. Journal of East China University of Science and Technology, 2017, (6): 806-814. doi: 10.14135/j.cnki.1006-3080.2017.06.009

CHO细胞培养生产抗体产量的稳定性

doi: 10.14135/j.cnki.1006-3080.2017.06.009

Titer Stability of Antibody Produced by CHO Cell Culture

  • 摘要: 实现了中国仓鼠卵巢(CHO)细胞高密度培养过程的稳定。以表达IgG抗体的流加培养过程为研究对象,首先通过"鱼骨图"分析、FMEA风险评估剖析潜在的关键控制参数,其次通过DOE (实验设计)方法确定和优化关键控制参数及其范围。结果表明,在99个培养过程参数中搜寻并确认了8个关键控制参数及其范围。经优化控制后,表达IgG抗体的流加培养过程批次间抗体产量差异从200%下降至10%。基于QbD理论,能快速有效地实现CHO细胞培养生产抗体产量的稳定性,有利于保证抗体药物生产的安全性以及保障企业的经济效益。

     

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出版历程
  • 收稿日期:  2017-05-04
  • 刊出日期:  2017-12-28

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